SGLT-2 inhibitor Jardiance to expand HF indication

Second SGLT-2 inhibitor after Forxiga, Jardiance under review by Japanese health authority

EMPEROR-Reduced confirmed efficacy, regardless of diabetes

Following after Forxiga, Jardiance is also preparing to introduce the heart failure indication in South Korea.

 

According to a pharmaceutical industry insider, Boehringer Ingelheim Korea is waiting for the health authority’s review result in its sodium-glucose cotransporter 2 (SGLT-2) inhibitor Jardiance’ request to expand indication in treating adult patients with heart failure with reduced ejection fraction (HFrEF) regardless of diabetic status.

 

The South Korean authority has approved the same indication in competing Forxiga (dapagliflozin) in last December.

 

The U.S.

 

Food and Drug Administration (FDA) has reportedly granted a fast-track status on Jardiance’ indication, which is also under review in other countries like Japan.

 

The drug’s efficacy in heart failure treatment has been statistically confirmed by a Phase III EMPEROR-Reduced trial.

 

The study verified Jardiance met the primary endpoint by demonstrating 25 percent lower risk in cardiovascular related death or hospitalization by a heart failure, compared against placebo.

 

Evaluating the secondary endpoint, Jardiance lowered the risk of a first hospitalization by a heart failure and repeated hospitalization by 30 percent.

 

And for a new indicator, the decrease in estimated glomerular filtration rate (eGFR) by the drug was significantly delayed compared to the placebo.

 

In last year, American Society of Nephrology (ASN) also disclosed the result of sub-analysis on EMPEROR-Reduced trial at 'Kidney Week 2020.' The analysis studied various subgroups of patients, including groups with severe renal impairment, experienced the drug’s benefit regardless of the chronic renal disease.

 

The president of the Korean Society of Heart Failure and a cardiology professor at Seoul National University Bundang Hospital, Dr.

 

Choi Dong-ju noted, “The size of heart failure patients in South Korea has almost doubled within last decade.

 

The prevalence in heart failure will increase continuously in the future due to the aging society.

 

But it is satisfying to see the EMPEROR-Reduced trial showing a positive outcome in treating heart failure.” Meanwhile, the FDA has designated the fast-track review status on EMPEROR program, which consists of EMPEROR-Preserved and EMPEROR-Reduced trials on evaluating Jardiance’ efficacy in lowering the risk of cardiovascular related death and hospitalization by heart failure.

 

The EMPEROR-Preserved trial aims to assess Jardiance’ effect on cardiovascular related death and hospitalization by heart failure in patients with Heart failure with preserved ejection fraction (HFpEF).

 

Currently, the health condition does not have any specific treatment for it, and the trial result would be disclosed within this year.